XELJANZ® (tofacitinib citrate) Approved in Japan for the Treatment of Adults
with Rheumatoid Arthritis (RA)
NEW YORK -- March 25, 2013
Pfizer Inc. (NYSE: PFE) announced today that the Japanese Ministry of Health,
Labor and Welfare (MHLW) has approved XELJANZ^® (tofacitinib citrate) for the
treatment of adults with rheumatoid arthritis (RA) who have had an inadequate
response to existing therapies. XELJANZ may be used in patients in whom
clinical symptoms due to the disease remain even after appropriate treatment
with at least one other disease-modifying antirheumatic drug (DMARD), such as
methotrexate. The recommended dose of XELJANZ is 5 mg twice daily.
XELJANZ will be commercially available in Japan after the National Health
Insurance listing and will be co-promoted in Japan by Pfizer and Takeda
Pharmaceutical Company Limited. Pfizer and Takeda also currently co-promote
the RA drug Enbrel^® (etanercept) in Japan.
XELJANZ (ZEL’ JANZ’) is the first approved oral treatment in a new class of
medicines known as Janus kinase (JAK) inhibitors. Initially, XELJANZ will be
made available in Japan to medical institutions participating in an
all-patient surveillance program.
“RA is a serious and disabling disease and there is a need for new treatment
options, as a significant number of patients do not adequately respond to
current therapies,” said Mark Swindell, Head of Pfizer Specialty Care Business
Unit in Japan. “We are proud of our strong portfolio of treatments for
inflammatory disorders in Japan, and we are pleased with the approval of
XELJANZ, which allows us to offer an additional treatment option for RA
Unlike biologic therapies that target RA outside the cell, XELJANZ targets the
disease from inside the cell. It is specifically designed to inhibit the Janus
kinase (JAK) pathways, which are signalling pathways inside the cell that play
a role in the inflammation involved in RA.
The approval of XELJANZ in Japan is supported by a multi-study, global
clinical development program, which evaluated XELJANZ in approximately 5,000
patients across various RA patient populations. The application also included
data from Japanese subjects from two phase 2 studies, one phase 3 study and an
ongoing long-term extension study. Across five global pivotal trials, XELJANZ
5 mg twice daily demonstrated efficacy, whether administered alone or in
combination with a non-biologic DMARD, such as methotrexate, in patients who
had a previous inadequate response to non-biologic or biologic DMARDs,
including tumor necrosis factor (TNF) inhibitors.
XELJANZ is approved for the treatment of RA patients who have had an
inadequate response to existing therapies. Notable safety findings observed in
the XELJANZ RA program include serious and other important infections,
including tuberculosis and herpes zoster; malignancies, including lymphoma;
gastrointestinal perforations; decreased neutrophil and lymphocyte counts; and
lipid elevations. The most common serious adverse events were serious
infections. The most commonly reported adverse events were upper respiratory
tract infections, headache, nasopharyngitis and diarrhea.
About Rheumatoid Arthritis
Rheumatoid arthritis is a chronic inflammatory autoimmune disease that
typically affects the hands and feet, although any joint lined by a synovial
membrane may be affected. RA affects approximately 700,000 – 800,000 people in
Japan^1 and 23.7 million people worldwide.^2 Although multiple treatments are
available, many patients do not adequately respond. Specifically, up to
one-third of patients do not adequately respond and about half stop responding
to any particular DMARD within five years.^3,4,5,6,7,8 There remains a need
for additional options.
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^1 Report from Study Committee on Rheumatoid Arthritis and Allergy Accessed on
13 March 2013.
^2 World Health Organization, “The Global Burden of Disease, 2004 Update.”
Accessed 13 March 2012. Available at
^3 Klareskog L, Van der Heijde D, de Jager J, et al. Therapeutic effect of the
combination of etanercept and methotrexate compared with each treatment alone
in patients with rheumatoid arthritis: double-blind randomized controlled
trial. The Lancet 2004. 363: 675-681
^4 Keystone, E, Kavanaugh A, Sharp J, et al. Radiographic, clinical and
functional outcomes of treatment with adalimumab (a human anti-tumor necrosis
factor monoclonal antibody) in patients with active rheumatoid arthritis
receiving concomitant methotrexate therapy. Arthritis & Rheumatism 2004. 50:
^5 Lipsky, P, Van der Heijde, D, St. Clair, W. Infliximab and methotrexate in
the treatment of rheumatoid arthritis. The New England Journal of Medicine
^6 Duclos M, Gossec L, Ruyssen-Witrand A, et al. Retention rates of tumor
necrosis factor blockers in daily practice in 770 rheumatic patients. J
Rheumatol 2006; 33:2433-8.
^7 Maradit-Kremers H, Nicola PJ, Crowson CS, et al. Patient, disease, and
therapy-related factors that influence discontinuation of disease-modifying
antirheumatic drugs: a population-based incidence cohort of patients with
rheumatoid arthritis. J Rheumatol 2006; 33(2):248-55.
^8 Blum MA, Koo D, Doshi JA. Measurement and rates of persistence with and
adherence to biologics for rheumatoid arthritis: a systematic review. Clin
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